A Tasigna lawsuit may be an option for people who were treated with the drug and suffered serious adverse health consequences. Research suggests a link between the use of Tasigna to treat chronic myeloid leukemia (CML) and atherosclerosis, a disease that causes the arteries to thicken and harden due to the buildup of plaque. Lawsuits allege that, although doctors and patients were warned in Canada, the manufacturer failed to disclose known risks to doctors and patients in the United States. Affected patients and their families may be eligible to recover compensation with the help of a dangerous drug attorney.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Tasigna Lawsuit Commercial?
You may have seen a Tasigna lawsuit commercial on television and wondered whether you or a loved one have been affected by the cancer treatment and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is Tasigna?
Tasigna, also known generically as nilotinib, is an oral treatment for patients who have been diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (CML). Patients who are no longer benefiting from other treatments may be prescribed Tasigna as well. Philadelphia chromosome-positive CML is a long-term, treatable form of cancer that can become a chronic disease if not treated properly. According to the National Cancer Institute, CML is a disease in which the bone marrow makes too many white blood cells. Approximately 8,950 new cases of CML will be reported in the U.S. along with over one thousand deaths in 2017.
How Does Tasigna Work?
Tasigna belongs to a class of drugs known as tyrosine kinase inhibitors and works by targeting and blocking tyrosine kinases, specific proteins responsible for the activation, signaling and growth of certain cells. Targeted cancer treatments such as Tasigna work to stop leukemia cells from growing while lessening the risk of damage to healthy cells.
Tasigna and Atherosclerosis
Tasigna has been allegedly linked to atherosclerosis, a disease in which plaque builds up inside the arteries. According to the National Heart, Lung, and Blood Institute, atherosclerosis can affect any artery in the body, including arteries in the heart, brain, arms, legs, pelvis and kidneys. The lack of adequate blood circulation, primarily in the legs, can potentially lead to serious infections and tissue death that can sometimes require amputation.
Other Vascular Risks Linked to Tasigna
Atherosclerosis may lead to other diseases, including:
- Coronary Heart Disease
- Carotid Artery Disease
- Peripheral Artery Disease
- Chronic Kidney Disease
Likewise, studies have suggested a link between Tasigna and other tyrosine kinase inhibitors and arterial events. According to Haematologica (the official journal of the European Hematology Association), “evidence suggests that nilotinib has a propensity to increase the risk of occlusive arterial events, especially in patients with pre-existing cardiovascular risk factors.”
According to an article published in Cardio-Oncology in December 2015, several reports describe a possible relationship between the use of newer generation tyrosine inhibitors, including nilotinib (Tasigna), and vascular adverse events.
Other reports described in the article include:
- an examination of 24 CML patients treated with Tasigna in which three patients developed rapidly peripheral arterial occlusive disease (PAOD) during treatment, requiring repeated angioplasty and/or multiple surgeries;
- the clinical outcomes of 34 patients receiving nilotinib which indicated an increased percentage of patients suffering from arterial occlusive disease compared with matched control groups; and
- the description of a patient on nilotinib treatment with rapidly progressive intra- and extra-cranial atherosclerosis leading to stroke.
Tasigna Side Effects
Common side effects may include:
- Low blood count
- Muscle and joint pain
- Runny or stuffy nose, sneezing, sore throat
- Night sweats
Other Tasigna Side Effects
Serious side effects of Tasigna may include:
- Symptoms associated with low blood counts, including unexplained bleeding or bruising, blood in urine or stool, and unexplained weakness
- QT prolongation, a possible life-threatening heart problem characterized by a feeling of lightheadedness or irregular heartbeat
- Symptoms associated with decreased blood flow to the leg, heart or brain, including chest pain or discomfort, numbness or weakness, problems walking or speaking, leg pain, leg feels cold, or change in the skin color of your leg
- Liver damage
- Pancreatitis (inflammation of the pancreas)
- Bleeding in the brain
- Tumor Lysis Syndrome, which can cause someone to have kidney failure and the need for dialysis treatment as well as an abnormal heartbeat
Patients are advised to contact their doctor or health care provider if they develop signs and symptoms of bleeding and fluid retention.
Has There Been a Tasigna Recall?
Although there has not been a Tasigna recall, lawsuits claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result.
Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
While Tasigna has not been recalled, important safety information regarding the possible risk of developing atherosclerosis-related conditions with the use of Tasigna was issued to both the general public and health care professionals in Canada. According to two safety alerts published by Health Canada, “cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of Tasigna.” Patients and health care professionals were warned to watch for signs of atherosclerosis-related diseases.
Is There a Tasigna Class Action?
To date, a Tasigna class action has not been filed on behalf of patients who took the medication and suffered vascular adverse events, including atherosclerosis. Tasigna lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the drug. Instead, if multiple Tasigna lawsuits are filed against the drug makers alleging injuries and other damages caused by Tasigna and similar drugs, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by pharmaceutical products.
Have There Been Tasigna Settlements?
Some cases settle early in the claims process, but it is not expected that there will be early Tasigna settlements involving claims against the manufacturer for failure to disclose of the link between the drug and atherosclerosis. However, in 2015, Novartis agreed to pay $390 million to settle U.S. federal government charges that it paid specialty pharmacies illegal kickbacks in exchange for recommendations to fill certain medications, including Tasigna. According to Reuters, the drug company admitted to working with specialty pharmacies as well as details of the alleged scheme.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will be made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
It is expected that Tasigna settlements will follow this pattern, although the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.
Lauren A. on May 16, 2016
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Tasigna Lawsuit Claims
A wrongful death lawsuit filed in California in March 2016 alleges that Novartis, manufacturer of Tasigna, was aware of numerous reports indicating that the drug caused severe, accelerated and irreversible atherosclerosis in patients taking the drug. According to an article in HarrisMartin’s Drugs & Medical Devices Publication, the family of a California man claims that their deceased loved one died from an atherosclerosis-related condition and that Novartis failed to warn doctors and patients in the U.S. about dangerous side effects linked to the medication.
Tasigna Lawsuit News
- March 2016Wrongful death lawsuit filed in California alleges that Novartis failed to warn doctors and patients in the U.S. about the dangerous side effects linked to the medication, including the risk of atherosclerosis.
- November 2015Novartis agrees to settle with the U.S. government for $390 million after the drug company admitted to illegal kickbacks with specialty pharmacies in exchange for recommendations to Medicaid and Medicare patients.
- May 2013According to the American Journal of Hematology, researchers describe the rapid progression of intra- and extra-cranial atherosclerosis that led to a stroke in a patient with previously reported Tasigna-related peripheral arterial disease.
- April 2013Health Canada issues safety alert for general public and health care professional regarding the possible risk of developing atherosclerosis-related conditions with the use of Tasigna.
- 2013In an article published in the journal Blood, researchers suggest that the clinical outcomes of 34 patients receiving nilotinib indicate an increased percentage of patients suffering from arterial occlusive disease compared with matched control groups.
- April 2011In an article published in the American Journal of Hematology, researchers note that three patients developed rapidly peripheral arterial occlusive disease (PAOD) during treatment, and were required to have repeated angioplasty and/or multiple surgeries.
How a Tasigna Lawsuit Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Tasigna may be eligible to recover money for:
Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.